Source: European Medicines Agency (EU) Revision Year: 2021 Publisher: CO.DON AG, Warthestraße 21, 14513 Teltow, Germany
Repair of symptomatic articular cartilage defects of the femoral condyle and the patella of the knee (International Cartilage Regeneration & Joint Preservation Society [ICRS] grade III or IV) with defect sizes up to 10 cm² in adults and adolescents with closed epiphyseal growth plate in the affected joint.
Spherox is intended for autologous use only. It must be administered by a specialised orthopedic surgeon and in a medical facility.
10-70 spheroids are applied per square centimetre defect.
The safety and efficacy of Spherox in children and adolescents with still open epiphyseal growth plate in the affected joint have not been established. No data are available.
The safety and efficacy of Spherox in patients aged over 50 years have not been established. No data are available.
For intraarticular use.
Spherox is administered to patients by intraarticular implantation.
The implantation must be performed during a surgical procedure (preferably an arthroscopy or miniarthrotomy). A debridement of the defect area is required. The subchondral plate should not be damaged. The spheroids are provided in a pre-filled syringe or an applicator (stem length 150 mm (co.fix 150)). Spheroids should be applied evenly on the defect ground and, if necessary, spread over the whole defect area by means of surgical instruments. The spheroids self-adhere within 20 minutes onto the defect ground. Afterwards, the surgical wound can be closed without any additional cover of the treated area (e.g. periosteal flap; matrix), or any fixation of spheroids by using fibrin glue. The treatment of defect sizes up to 10 cm² is eligible for single as well as adjacent defects (combined area).
Patients treated with Spherox have to undergo a specific rehabilitation program (see section 4.4). The program may take up to one year depending on the recommendation of the physician.
For information on preparation and handling of Spherox, please refer to section 6.6.
In cases where the recommended dose was significantly exceeded (up to 170 spheroids/cm² in an investigator-initiated trial with a follow-up period of 12 months), no negative effects were observed.
72 hours.
Store at temperatures between 1°C and 10°C.
Do not freeze.
Do not irradiate.
Do not open the outer packaging before use to prevent microbial contamination.
The spheroids are provided in an applicator or a pre-filled syringe as primary packaging unit.
The applicator (stem length 150 mm (co.fix 150)) is packed in a sterile tube and additionally surrounded by an extra bag. A tube may contain a maximum of two co.fix 150. The catheter of the applicator is made of thermoplastic polyurethane, the sealing plug on one side of acrylonitrile butadiene styrene and a silicone stopper on the other side. The applicator is delivered with an application device (sterile injection syringe).
The pre-filled syringe consists of a luer lock, a sealing ring and a cover cap. It is packed in a sterile tube with a screw-type cap and additionally surrounded by an extra bag. All parts of the pre-filled syringe are made of polypropylene, the sealing ring of isoprene. Silicone oil serves as lubricant. The pre-filled syringe is delivered with an application device (indwelling cannula or filter stem).
The number of primary packaging units delivered depends on the type of the primary packaging unit and the number of spheroids necessary for the specific defect size (10-70 spheroids/cm²).
One applicator has a maximum capacity of 60 spheroids in a volume of up to 200 microlitre isotonic sodium chloride solution.
One pre-filled syringe has a maximum capacity of 100 spheroids in a volume of up to 1000 microlitre isotonic sodium chloride solution.
If the primary or secondary packaging is damaged and therefore unsterile, Spherox should not be applied.
Remaining spheroids must not be stored for later application.
Any unused product or waste material should be disposed in accordance with local requirements.
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